ABSTRACT The overall purpose of the Protocol Review and Monitoring System (PRMS) is to ensure that clinical research of the highest scientific caliber is conducted at the University of Hawai?i Cancer Center (UHCC) and throughout the large community-based network of hospitals, health systems and oncology providers within the UHCC-led clinical trials infrastructure. The PRMS consists of the Protocol Review and Monitoring Committee (PRMC). The PRMC review process ensures that all research is safe and scientifically sound with entry criteria that reflect the catchment area patient population, have a high probability of full accrual, do not compete with each other, have adequate resources to answer the question being asked, and is consistent with the priorities of the UHCC. Pre-PRMS evaluations are completed by the Translational and Clinical Research (TCR) Steering Committee, the Community Research Advocacy Board (CRAB) and review of data safety and monitoring plans by the Data Safety and Monitoring Committee (DSMC). The outcome from each of these evaluations is submitted to the PRMC for reference, ensuring that each protocol receives a thorough, high quality peer review. The PRMC review occurs prior to the submission to the Institutional Review Board (IRB). PRMS functions are independent of the IRB, and do not duplicate or overlap with the responsibilities of the IRB. The PRMS has the authority to open protocols that meet the scientific merit and priorities of the UHCC and to terminate protocols that do not demonstrate scientific progress. The PRMC is comprised of senior clinical oncology investigators from a wide range of disciplines. Members receive training and evaluate all cancer protocols. Special emphasis is placed on the review of investigator-initiated trials (IITs) that have not had other external scientific review. From January 1, 2012 through June 30, 2017, the PRMC reviewed 218 new protocols, of which 191 were approved and 27 were not approved. During this period, 275 were reviewed by the PRMC for annual monitoring. Of these, 25 were disapproved for continuation, primarily due to low or slow accrual that would prevent achievement of the scientific goals. PRMC efficiency is monitored through ePRMS tracking within OnCore and includes volume tracking and tracking of time frames from submission to approval.